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Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00410072
First received: December 11, 2006
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: November 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic
Interventions: Drug: Entecavir
Drug: Entecavir + Tenofovir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
669 participants were enrolled; 384 were randomized. Among 285 who were not randomized, 266 did not meet the study criteria, 11 other, 1 poor compliance/noncompliance, 4 lost to follow-up, 1 withdrew consent, and 2 for administrative reasons.

Reporting Groups
  Description
ETV 0.5 mg Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
ETV 0.5 mg +TDF 300 mg ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks

Participant Flow for 2 periods

Period 1:   Day 1 to Week 48
    ETV 0.5 mg   ETV 0.5 mg +TDF 300 mg
STARTED   182 [1]   197 [2] 
COMPLETED   176   185 
NOT COMPLETED   6   12 
Adverse Event                1                2 
Lost to Follow-up                5                2 
Not specified                0                1 
poor compliance/noncompliance                0                3 
Pregnancy                0                2 
Withdrawal by Subject                0                2 
[1] Number of participants randomized and treated; 4 more were randomized but not treated.
[2] Number of participants randomized and treated; 1 more was randomized but not treated.

Period 2:   After Week 48 to Week 96
    ETV 0.5 mg   ETV 0.5 mg +TDF 300 mg
STARTED   176   185 
COMPLETED   170   174 
NOT COMPLETED   6   11 
Adverse Event                1                2 
Death                0                1 
Lack of Efficacy                1                0 
Lost to Follow-up                2                4 
Not specified                2                0 
Poor compliance/noncompliance                0                1 
Pregnancy                0                2 
Withdrawal by Subject                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ETV 0.5 mg Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
ETV 0.5 mg +TDF 300 mg ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
Total Total of all reporting groups

Baseline Measures
   ETV 0.5 mg   ETV 0.5 mg +TDF 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 182   197   379 
Age, Customized 
[Units: Participants]
     
16 - 20 years   13   19   32 
21 - 64 years   157   169   326 
>=65 years   12   9   21 
Gender 
[Units: Participants]
     
Female   66   51   117 
Male   116   146   262 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   84   102   186 
Black/African American   10   4   14 
Native Hawaiian/Other Pacific Islander   1   1   2 
White   83   87   170 
Other   4   3   7 
Country 
[Units: Participants]
     
United States   35   43   78 
Turkey   11   11   22 
Russian Federation   24   23   47 
Italy   12   15   27 
India   5   9   14 
France   8   5   13 
Canada   29   33   62 
Argentina   12   15   27 
Poland   15   13   28 
Brazil   5   3   8 
Australia   24   24   48 
South Africa   2   3   5 
Region 
[Units: Participants]
     
Africa   2   3   5 
Asia   29   33   62 
Europe   70   67   137 
North America   64   76   140 
South America   17   18   35 
Hepatitis B e antibody (HBeAb) at baseline 
[Units: Participants]
     
Positive   60   60   120 
Negative   122   137   259 
Hepatitis B e antigen (HBeAg) status at baseline 
[Units: Participants]
     
Positive (> 172,000 IU/mL; approx 10^6 copies/mL)   126   138   264 
Negative (> 17,200 IU/mL; approx 10^5 copies/mL)   56   59   115 
Hepatitis B surface antigen (HBsAg) status at baseline 
[Units: Participants]
     
Positive   182   196   378 
Negative   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96   [ Time Frame: At Week 96 ]

2.  Secondary:   Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status   [ Time Frame: At Weeks 48 and 96 ]

3.  Secondary:   Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

4.  Secondary:   Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

5.  Secondary:   Mean Log 10 HBV DNA at Weeks 48 and 96   [ Time Frame: Baseline, Weeks 48 and 96 ]

6.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

7.  Secondary:   Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

8.  Secondary:   Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

9.  Secondary:   Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

10.  Secondary:   Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

11.  Secondary:   Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 ]

12.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities   [ Time Frame: From enrollment through Week 100 + 24-week follow-up ]

13.  Secondary:   Number of Participants With HBV Resistance Through Week 48   [ Time Frame: Week 48 ]

14.  Secondary:   Number of Participants With HBV Resistance at Week 96   [ Time Frame: Week 96 ]

15.  Secondary:   Number of Participants With Virologic Breakthrough at Week 48   [ Time Frame: Week 48 ]

16.  Secondary:   Number of Participants With Virologic Breakthrough at Week 96   [ Time Frame: Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00410072     History of Changes
Other Study ID Numbers: AI463-110
Study First Received: December 11, 2006
Results First Received: November 4, 2011
Last Updated: March 13, 2013